Follow-up Study of L059 (Levetiracetam) in Epileptic Patients With Partial Onset Seizures by Open Label Method

Phase 3

Completed

• Conditions: Epilepsy, Partial
• Interventions: Drug: Levetiracetam

• Registration Number: NCT00160615
• Lead Sponsor: UCB Japan Co. Ltd.

Brief Summary

The safety and efficacy of L059 was evaluated in patients who completed "N165 Clinical Trial of L059". They received L059 at a daily dose from 1,000 mg to 3,000 mg in addition to their standard concomitant AEDs

Detailed Description

Not available

Study Timeline

• Study Start: 2001-09-12
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-08
• Study First Posted: 2005-09-12
• Primary Completion: 2007-01-17
• Study Completion: 2007-01-17
• Results First Submitted: 2018-09-18
• Status Verified: 2019-03
• Results First Submitted QC: 2019-03-08
• Last Update Submitted: 2019-03-08
• Results First Posted: 2019-06-10
• Last Update Posted: 2019-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 154

Inclusion Criteria

• Patients who completed the evaluation period (Week 16) of N165 Clinical Trial of L059
• Patients/the parent or guardian wish to continue treatment with L059 and to enter N165 Follow-up Study, and also the investigator admit the necessity of the repeated intake of the investigational drug for the patients.

Exclusion Criteria

• Patients who had not participate in N165 Clinical Trial of L059.
• Patients who had participated in N165 Clinical Trial of L059 with no intention of entering the follow-up study taking the same medication.
• Patients had not been in compliance with requirements of Protocol for N165 Clinical Trial of L059 in the course of the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Levetiracetam	Levetiracetam	Subjects received oral tablets of Levetiracetam. This study N01020 (NCT00160615) was designed as a single group assignment study and as follow-up study, open for patients from N165 (NCT00600509). The differentiation into placebo and Levetiracetam in the results reporting section is based on the treatment of the previously conducted study N165 (NCT00600509).

Primary Outcome Measures

Name	Time	Method
Partial (Type I) Seizure Frequency Per Week by Analysis Visit	From Baseline up to 54 months	Number of Partial (Type I) seizures over the treatment period standardized to 1 week period.
Partial (Type IA) Seizure Frequency Per Week by Analysis Visit	From Baseline up to 54 months	Number of Partial (Type IA) seizures over the treatment period standardized to 1 week period.
Partial (Type IB) Seizure Frequency Per Week by Analysis Visit	From Baseline up to 54 months	Number of Partial (Type IB) seizures over the treatment period standardized to 1 week period.
Partial (Type IC) Seizure Frequency Per Week by Analysis Visit	From Baseline up to 54 months	Number of Partial (Type IC) seizures over the treatment period standardized to 1 week period.

Secondary Outcome Measures

Name	Time	Method
Percentage Change From Baseline of Partial Onset Seizure Frequency (Type I Overall) Per Week by Analysis Visit	From Baseline up to 54 months	Percentage change from baseline of of Partial (Type I) seizure frequency over the treatment period standardized to 1 week period.; Negative values indicate improvement from Baseline.
Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IA) Per Week by Analysis Visit	From Baseline up to 54 months	Percentage change from baseline of of Partial (Type IA) seizure frequency over the treatment period standardized to 1 week period.; Negative values indicate improvement from Baseline.
Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IB) Per Week by Analysis Visit	From Baseline up to 54 months	Percentage change from baseline of of Partial (Type IB) seizure frequency over the treatment period standardized to 1 week period.; Negative values indicate improvement from Baseline.
Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IC) Per Week by Analysis Visit	From Baseline up to 54 months	Percentage change from baseline of of Partial (Type IC) seizure frequency over the treatment period standardized to 1 week period.; Negative values indicate improvement from Baseline.